MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Catalog Number	CAT8TORQ85
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat8 was fractured approximately 1.5 cm from the hub.The cat8 was kinked approximately 69.5 and 94.0 cm from the hub.Conclusions: evaluation of the cat8 revealed that the device was fractured.If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur.Further evaluation of the returned device revealed kinks in the catheter shaft.These kinks were likely incidental and may have occurred while packaging the device for return to penumbra.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff found that the indigo system aspiration catheter 8 (cat8) was torn upon removal from the packaging.The damage to the cat8 was found prior to use.Therefore, the cat8 was not used in the procedure.There is no information regarding how the procedure was completed.
Additional Manufacturer Narrative
The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7545056
• Report Number: 3005168196-2018-01055
• Device Sequence Number: 18876140
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CAT8TORQ85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005